Monday, April 30, 2012

Last week, Senator Dick Durbin (D-IL) urged the Food and Drug Administration (FDA) to close a loophole in the Tobacco Act, enacted in 2009, by banning flavored cigars. The Tobacco Act banned flavored cigarettes, but not flavored cigars. To close this loophole, which Senator Durbin said is being exploited by tobacco companies to attract youth to tobacco use, Senator Durbin is calling on the FDA to extend the flavoring ban to cigars.

"“In 2009, President Obama signed an important new law – the Family Smoking Prevention and Tobacco Control Act – that expanded the authority of the FDA to regulate all tobacco products. Because the law banned flavored cigarettes, many companies turned to flavored cigars to help attract and retain young customers. Cigars with candy-like flavorings such as strawberry, watermelon, vanilla and chocolate are marketed to young people, and get them hooked on this deadly and addictive habit at a
young age. This provision encourages the FDA to assert its authority and take the necessary steps to curb the use of these dangerous products,” Durbin said.

"“The emergence of flavored cigars is a transparent effort by Big Tobacco to work around the new tobacco control law. These flavored cigars are clearly designed to attract young adults and hook the next generation of tobacco users from an early age. This amendment is an important step to ensure the FDA uses its full authority to place reasonable standards on the tobacco industry and keep our kids healthy and safe,” Lautenberg said."

"Although the Tobacco Control Act banned flavored cigarettes, some
companies are avoiding the ban by marketing their products as flavored
cigars, which are not prohibited by law."

The Rest of the Story

The exemption of flavored cigars is hardly the only, or the most important loophole in the Tobacco Act as it relates to the banning of flavored tobacco products that may appeal to children. The most important loophole is the exemption of menthol cigarettes, which - unlike the cherry, pineapple, banana, and raspberry cigarette flavorings which were banned - are actually smoked by a substantial proportion of youth smokers, about 50% to be exact.

This exemption of menthol cigarettes in the Tobacco Act is largely a result of Senator Durbin's efforts, as he helped coordinate the negotiations between the Campaign for Tobacco-Free Kids and Philip Morris which led to the Act. Senator Durbin, along with the health groups, were opposed to an amendment which would have removed the menthol exemption. Apparently, he isn't as committed to banning products that "attract young adults and hook the next generation of tobacco users" as he claims to be.

If Senator Durbin were truly committed to banning products that "attract young adults and hook the next generation of tobacco users," then certainly he would be including in his demand to the FDA an insistence that the agency also ban menthol cigarettes, since these are flavored cigarette products with widespread appeal to youth smokers and which have been demonstrated to play a significant role in the smoking initiation process by making early smoking experiences more pleasant (menthol is an anaesthetic which soothes the airways and decreases the harshness and irritation produced by smoke, which is especially important in not turning youth away during their initial experiences with cigarettes).

While I am not necessarily arguing here that menthol cigarettes should be banned, I am pointing out that once a politician stands up and argues that he is a champion for the public's health because he is committed to getting rid of flavored tobacco products that appeal widely to young people, that politician is a complete hypocrite if he does not also push for the removal of menthol-flavored cigarettes from the market.

Moreover, why is Senator Durbin not calling on the FDA to ban Marlboro, Camel, and Newport cigarettes? After all, if the criterion for justifying the banning of a tobacco product is that it should be banned if it appeals widely to young people, then certainly Marlboro, Camel, and Newport should be the very first products to go since they account for about 90% of the cigarettes smoked by youth. These three brands are overwhelmingly popular among youth, have widespread appeal among these young smokers, and clearly are getting youth "hooked on this deadly and addictive habit at a
young age," just as Senator Durbin claims watermelon cigars are doing.

For this reason, I am awarding Senator Durbin the 2012 Rest of the Story's Hypocrisy of the Year Award. This is quite an accomplishment, especially considering that we are only four months into the year. However, I am so impressed with this degree of hypocrisy that I cannot imagine that it will be topped in this calendar year.

Thursday, April 26, 2012

In an action alert posted on its web site yesterday, the Campaign for Tobacco-Free Kids is urging the public to join the organization in lambasting Family Dollar for its decision to start selling tobacco products.

According to the alert: "The Campaign for Tobacco-Free Kids and Break Free Alliance, which works to reduce tobacco use among low-income Americans, have written to Family Dollar
urging that the company immediately reverse this decision to protect
its customers' health and stay true to its name as a business that
values families. Other organizations calling on Family Dollar to reverse
its decision include the American Academy of Pediatrics, Legacy, the
National Latino Tobacco Control Network and the Inter-tribal Council of
Michigan. "Given the devastating toll of tobacco use on America's children and
families, we believe your decision is an enormous step in the wrong
direction," the health groups wrote in a letter to Family Dollar
Chairman and CEO Howard Levine. "Selling tobacco to your customers will make it easier for them to
become addicted or sustain an existing addiction and suffer the dire
economic and health consequences of tobacco use. The fact that your
customer base is comprised of low-income families makes your decision
even more troubling. Low-income people smoke more, suffer more, spend
more and die more from tobacco use .... Sales of tobacco products at
Family Dollar stores will only worsen these terrible burdens and health
disparities."

The Rest of the Story

What I don't understand is that if sales of tobacco products at stores whose customers may be comprised of low-income families worsens the terrible burden of tobacco-related disease and increases health disparities, then why is the Campaign for Tobacco-Free Kids not also calling for the following other stores to also discontinue the sale of cigarettes:

Why is the Campaign for Tobacco-Free Kids not also sending a letter to each of the stores listed above saying: "Selling tobacco to your customers will make it easier for them to
become addicted or sustain an existing addiction and suffer the dire
economic and health consequences of tobacco use."

I don't understand how if Family Dollar sells cigarettes, it will make it easier for their customers to become addicted or sustain existing addiction and suffer the dire economic and health consequences of tobacco use, but if Uni-Mart sells cigarettes, it does contribute towards its customers suffering the dire consequences of tobacco use.

I also don't see how the decision about whether or not to sell cigarettes at Family Dollar will affect the public's health. Does the Campaign for Tobacco-Free Kids really believe that smokers who are addicted to cigarettes will quit smoking only if Family Dollar does not sell cigarettes? And does the Campaign believe that teenagers who are interested in smoking will decide not to start smoking if they are unable to purchase cigarettes at the local Family Dollar store?

What this action does, however, is frame the sale of cigarettes as being perfectly acceptable and no threat to the public's health as long as it is not done at particular types of stores, especially those with "Family" in their names. In other words, the message that the Campaign for Tobacco-Free Kids is sending is not that the sale of cigarettes contributes towards human disease and suffering, but instead, that stores with the word "Family" in their name shouldn't sell cigarettes, but if you don't have "Family" in your name, it's perfectly fine to sell cigarettes. This frames the problem of tobacco sales in exactly the wrong way. It is not, apparently, the tobacco that is the problem. It's the fact that it is being sold by the wrong store.

The Campaign for Tobacco-Free Kids seems to have an obsession with interventions that look good politically and rouse up constituent donations, but which don't actually do anything to put a dent in smoking rates.

Wednesday, April 25, 2012

A new study published in Tobacco Control reports the results of a qualitative examination of the emotional impact of graphic cigarette warning labels. Volunteers were shown 35 different graphic cigarette warning labels developed by the European Commission and rated their emotional reactions. The study found that very few of the warnings (only 4 of the 35) elicited high levels of arousal, therefore suggesting that these warnings are largely ineffective in influencing behavior. Among youth, the messages were even less effective in eliciting emotional arousal. And to make matters worse, a significant number of images (17%) actually elicited positive responses.

The study concludes: "If the aim of the European anti-tobacco campaign, based on aversive warning images, is to prompt negative attitudes towards smoking and predispose smokers to quit smoking by activating the defensive-avoidance motivational system, our results question the effectiveness of most of the proposed images. ... Considering that young people are currently one of the main marketing targets of tobacco firms in the world, the proposed tobacco-warning images might be particularly ineffective for this target population unless more arousing unpleasant pictures are used. ... the present results suggest that the warning images proposed by the European Commission for tobacco packages might have limited effectiveness in reducing tobacco consumption in the general population because most of the proposed images were evaluated as [only] moderately unpleasant and arousing. Because such images may not be capable of inducing negative attitudes and avoidance behaviors, the question of their effectiveness remains open."

The Rest of the Story

This study adds to a growing body of evidence that the graphic cigarette warning labels which are the centerpiece of the FDA's strategy to reduce tobacco use are likely to be only marginally effective.

This research adds to a body of psychology and neurophysiology research
which suggests that graphic warning labels on cigarette packages will
have very little effect in either deterring smoking among existing smokers who
are addicted to cigarettes or among youth.

While almost no scientific studies support the hypothesis that graphic
warning labels will cause smokers to quit, a wide range of evidence
suggests that this intervention is unlikely to be very effective.

I believe that if the national anti-smoking groups and members of
Congress truly wished to reduce smoking rates, they should have implemented the
tobacco companies' recommendations, rather than relying upon warnings on the cigarette packs to discourage
smoking.
The tobacco companies' recommendation for the federal government was to "use its power under the Spending Clause ... to condition receipt of
federal funds on States’ allocation of MSA funds in accordance with CDC
recommendations."

I believe that if the national anti-smoking groups and members of
Congress who supposedly want to reduce smoking rates had implemented the
tobacco companies' recommendations, rather than become obsessed with
the inane idea of asking the FDA to regulate the "safety" of tobacco
products and relying upon warnings on the cigarette packs to discourage
smoking, the field of tobacco control would be in a drastically better
place than it is today.

Imagine if all 50 states implemented tobacco control programs
similar to that in California, the only state with a sustained,
comprehensive tobacco control program for the past two decades. Imagine
if all states implemented anti-smoking television commercials like those
used in the "truth" campaign.

This is where the anti-smoking groups and Congress should have
directed their efforts over the past five years, rather than creating an
untenable system by which the agency charged with protecting the
nation's food and drug supply is charged with somehow ensuring that
cigarettes are "safe," which is an impossible task that wastes precious
resources and the centerpiece of the anti-smoking strategy is to scare people using graphic warning labels that in reality engender very little emotional response.

I think it is embarrassing that at the end of the day, the tobacco
companies - and not the national anti-smoking groups (i.e, Campaign for
Tobacco-Free Kids, American Cancer Society, American Heart Association,
American Lung Association, etc.) - have put together an effective
strategy for reducing tobacco use, while the national anti-smoking
groups have instead created a purposeless federal bureaucracy that is
going to spend millions of dollars but effect no substantial changes in
either cigarette safety or cigarette smoking rates.

The
rest of the story is that the graphic warning labels are yet another
part of the hoax that is the Family Smoking Prevention and Tobacco
Control Act. This legislation was designed to make it look like
politicians and health groups were fighting Big Tobacco when in fact,
the legislation does virtually nothing to put a significant dent in
smoking rates.

Tuesday, April 24, 2012

According to an article at Health Day, an orthopedic surgeon has recommended that patients who smoke should not be allowed to undergo joint replacement surgery, as a recent study shows that smokers have a significantly higher rate of failure and complications following this type of surgery.

The recommendation came at a forum on joint replacement surgery held at the annual meeting of the American Academy of Orthopaedic Surgeons in San Francisco last week, where two studies were presented which showed substantially higher rates of surgical failure and surgical complications in smokers following joint replacement or joint reconstruction surgery.

According to the article: "At the forum, experts offered suggestions about how to get patients to
quit smoking. One way is to refuse to perform surgery on patients who
smoke, said Dr. Glenn Rechtine, an orthopedic surgeon and associate
chief of staff and adjunct professor at the University of South Florida
in Tampa. He said this rule has convinced 40 percent of his patients to
stop smoking."

The Rest of the Story

Perhaps I'm misinterpreting his comment, but from what Dr. Rechtine stated, it appears that 60% of his smoking patients who need knee replacement surgery fail to qualify for this surgery because they are unable to quit smoking. In essence, these patients are being deprived a needed surgery as a punishment for being addicted to cigarettes. This is a harsh and brutal punishment that is not only inappropriate, but is in violation of the basic principles of medical practice.

The punishment will not only result in pain and suffering for these patients, but it will decrease their quality of life, as they will be unable to ambulate, exercise, and obtain physical activity to the degree they would like to. This, of course, will also have adverse health implications for them. Why should these people be punished so severely -- by the refusal of needed medical treatment and the imposition of pain and a decreased quality of life - for being unable to break an addiction that only 3% of smokers in the general population are able to break each year?

Fortunately, the rest of the physicians speaking at the forum appeared to have a more enlightened view on the subject and none of them echoed Dr. Rechtine's suggestion of refusing surgery to smokers.

Monday, April 23, 2012

The 2012 National Conference on Tobacco or Health, to be held this August in Kansas City, is the nation's premiere tobacco control conference. One of the major purposes of the conference is: "Learning the latest evidence on what works in tobacco control." In other words, it purports to be a scientific conference that objectively assesses the evidence of what works or does not work in tobacco control.

Today, I reveal that the 2012 National Conference on Tobacco or Health is sponsored by Pfizer, a pharmaceutical company that manufactures Chantix, a major smoking cessation drug. Pfizer is listed as a "Silver" sponsor. The benefits of this sponsorship for Pfizer include the following:

"Sponsor recognition in all printed conference materials";

"Sponsor recognition on all print and web materials";

"Complementary exhibit booth space";

"Complementary program ad space";

"Complementary usage of conference participant list"; and

"Sponsor logo and website link on the NCTOH website."

The Rest of the Story

The National Conference on Tobacco or Health has sacrificed its scientific
integrity for money. By accepting this sponsorship from Pfizer, the
conference has assured that no objective and unconflicted discussion of the
effective strategies for smoking cessation can take place.

For
example, how can an objective discussion of the risks of Chantix use
possibly occur at the conference? To be sure, the conference is not
going to highlight or even accept any talks on the deaths caused by
Chantix. Doing so would risk future sponsorship.

How can one
expect that the conference will include in the program a talk on the
hundreds of cases of violent and often fatal adverse effects that have
been reported with Chantix when the drug's manufacturer is a major
sponsor of the conference?

This pharmaceutical sponsorship
creates, by its very existence, an unavoidable bias that precludes a
truly objective consideration of any scientific issue that may have
significant implications for the profitability of smoking cessation
drugs, and therefore, for their manufacturers who are conference
sponsors. This bias does not necessarily have to be conscious. In fact,
the most concerning bias is that which could arise subconsciously by
virtue of the sponsorship of the conference by Big Pharma.

There
will, to be sure, be numerous papers presented about the effects of smoking cessation
drugs. How can these papers present a completely objective picture of
the efficacy of these medications when the manufacturers of these drugs
are the very sponsors of the conference?

This is in no way to
fault the individual scientists who will present on these issues at the
conference. Nor is it to suggest that any wrongdoing is occurring. It is
merely to point out that the pharmaceutical sponsorship creates, by its
very existence, an unavoidable bias that precludes a truly objective
consideration of any scientific issue that may have significant
implications for the profitability of smoking cessation drugs, and
therefore, for their manufacturers who are conference sponsors.

The
rest of the story is that the funding by Pfizer creates a substantial
conflict of interest that precludes the objective consideration of
many important scientific issues; in particular, the role of smoking
cessation drugs as part of national tobacco control strategies.

To make matters even worse, by virtue of the benefits given to sponsoring companies, the National Conference on Tobacco or Health is serving as a marketing partner for Pfizer. It is helping Pfizer to market its products by, for example, providing complementary advertising space and by providing the conference participant list, as well as by placing the company logo on its website.

And all this for what? Very simple. For money.

It is sad for me to see the tobacco control movement sacrificing its scientific integrity and undermining the public's trust simply for financial reasons.

I call on the National Conference on Tobacco or Health to return Pfizer's money and to institute a policy of rejecting pharmaceutical company sponsorship of its conferences. Otherwise, it can no longer claim to be an objective scientific conference which serves the purpose of undertaking an objective, evidence-based consideration of "the latest evidence on what works in tobacco control."

Friday, April 20, 2012

The American Legacy Foundation released a policy statement on electronic cigarettes, in which it called for the removal of these products from the market. The statement was entitled "The FDA Should Take Electronic Cigarettes Off The Market Until It Is Satisfied That They Are Safe and Effective."

According to the statement: "While we remain open to promising products that can help smokers quit smoking, a consideration of all of the available evidence combined with important unanswered questions strongly supports our call on the FDA to prohibit the marketing and sale of e-cigarettes unless and until the FDA is satisfied that they are safe and effective."

I have already explained why this is an inappropriate policy suggestion that would result in severe public health harm. There is little doubt that these products are helping literally thousands of people to remain smoke-free and that removing them from the market would result in thousands of ex-smokers returning to cigarette smoking because e-cigarettes are no longer available. I have also explained how this policy statement misrepresents the scientific evidence, as it suggests that electronic cigarettes present a carcinogenic risk, although the actual laboratory findings show that only trace levels of carcinogens are present in these products, comparable to the levels of carcinogens present in nicotine gum and nicotine patches -- products which the American Legacy Foundation has no concerns regarding safety. Moreover, the levels of carcinogens in electronic cigarettes are more than 1000 times lower than in Marlboros, meaning that these products can dramatically reduce a smoker's cancer risk.

This commentary, however, focuses on another issue: the question of the objectivity of the policy statement and whether or not Legacy appropriate revealed conflicts of interest that may be perceived as affecting Legacy's position and its reporting of the scientific evidence.

The Rest of the Story

The rest of the story is that the American Legacy Foundation has taken money from Big Pharma. In 2009-2011, it acknowledges having accepted donations from the following pharmaceutical companies, many of which manufacture smoking cessation products:

GlaxoSmithKline

Pfizer

Novartis

Schering-Plough

The receipt of this money represents a conflict of interest that I believe must be disclosed in any statement in which Legacy is making recommendations for national policy regarding electronic cigarettes. However, I cannot find any financial disclosure in the policy statement which informs the public that Legacy receives significant funding from the pharmaceutical industry.

This funding is highly relevant because electronic cigarettes represent a major potential threat to pharmaceutical company profits. If electronic cigarettes prove to be effective and continue to increase in popularity, they could put a huge dent in pharmaceutical smoking cessation drug sales, causing billion dollar losses for the pharmaceutical companies. This could threaten Legacy's future funding. Thus, by accepting this funding, Legacy has a vested financial interest in the stability of these pharmaceutical companies, and therefore, in the continued high rates of sale of their smoking cessation drugs. Electronic cigarettes threaten those high rates of sale, especially because preliminary evidence suggests that they may actually be far more effective than traditional pharmaceutical approaches to smoking cessation.

I believe that the American Legacy Foundation should have disclosed its financial conflict of interest.

Wednesday, April 18, 2012

As I reported here in the very first entry on this blog, back in March 2005, the American Legacy Foundation embraced Time Warner as its leading corporate partner in 2005-2006 and honored Time, Inc. with an award at a $500-a-plate fundraiser in Manhattan in 2005 because some of Time's magazines did not accept tobacco advertising.

As I wrote:

"At a $500-per-plate fundraiser at Cipriani's in Manhattan on Feb. 28, the American Legacy Foundation honored Time Inc. for "reaching millions with an anti-tobacco message." The dinner invitation page that describes Time Inc.'s qualifications for receiving Legacy's Progress in Media Award features pictures of five Time Inc. magazines: Real Simple, Health, Baby Talk, Cooking Light, and Parenting. According to the dinner invitation, the Legacy Foundation is "gratified that a selection of Time, Inc.’s magazines ... do not accept any tobacco product advertising.”" ...

"While Time Inc.'s adult-oriented magazines like Baby Talk and Parenting may not take tobacco ads, its publications that reach enormous youth audiences expose millions of adolescents to large numbers of cigarette and smokeless tobacco ads each week. According to a March 4 article in The Cancer Letter, the more than 125 Time Inc. magazines not pictured on the Legacy Honors invitation all accept tobacco advertising, with the five magazines pictured being the only ones that do not."

"The truth is that Time Inc. exposes millions of teenage readers to tobacco ads each week. Last year alone, four Time Inc. magazines (TIME, Entertainment Weekly, People, and Sports Illustrated) combined to expose over 4 million adolescents to 219 tobacco ads, up from the 138 tobacco ads that these magazines carried in 2001. And in the first two months of this year, the 22 tobacco ads that appeared in these publications (including cigarette company promotional ads) exceeded the 14 tobacco ads during the same period last year."

It is now six years later and the two largest cigarette companies (Philip Morris and R.J. Reynolds) have discontinued advertising in magazines. Many magazines no longer carry cigarette advertising at all.

The Rest of the Story

Despite the tremendous progress that has been made in reducing youth exposure to cigarette advertising in magazines, an article in the Business Insider - entitled "Cigarette Advertising Is On The Increase Again—And It's Entertainment Weekly's Fault" - reports that there has been a huge increase in cigarette advertising in magazines in the first quarter of 2012, with the second leading culprit being ...

... Time, Inc.

According to the article: "Cigarette advertising came back to the magazine business with a vengeance in Q1 2012, up 11 percent to 160 pages, according to Magazine Radar. The rest of the magazine ad business is in decline. ... Tobacco advertising has been down in recent years as stricter regulations prevented most companies from promoting their product. But a complete ban on tobacco promotion is not permitted by the First Amendment, according to the U.S. Supreme Court. The company that won that ruling, Lorillard, has taken full advantage. Ad page placements for its Newport brand went up for a second straight year, according to Magazine Radar, by 67 percent to 65 total pages. ... The most-favored magazines for cigarette ads are Motor Trend, Entertainment Weekly and National Enquirer."

Entertainment Weekly is owned by none other than Time, Inc.

So seven years after being honored by the American Legacy Foundation as an award-winning leader in the anti-tobacco movement, a Time, Inc. publication is now the second leading culprit in still accepting tobacco advertising and continuing to expose our nation's youth to cigarette advertising in magazines. In fact, youth are being exposed at an increasing, not decreasing rate according to the Business Insider. This is of particular concern for African-American youth as Newport, the most heavily advertised brand, is preferred overwhelmingly by African American smokers.

Entertainment Weekly is exposing more than 1 million youth readers to these Newport advertisements, at a time when we thought cigarette advertisements in magazines had ceased to be a problem.

The rest of the story is that the American Legacy Foundation's partnership backfired, as rather than encourage Time, Inc. to discontinue all advertising in magazines, it rewarded the corporation for being a leading carrier of cigarette advertising, taking all pressure off the company to stop accepting cigarette ads. When Lorillard came to Time, Inc. with a request to increase its cigarette advertisements in the first quarter of 2012, Time, Inc. was apparently only too happy to accept.

Moreover, I don't see Legacy attacking Time, Inc. for continuing to accept cigarette advertising, and for one of its magazines being a leading source of exposure of youth to Newport advertising so far in 2012. The corporate partnership appears to have bought off not only praise from Legacy, but to have also bought silence.

After giving an award to Time, Inc. for supposedly being a leader in preventing youth exposure to cigarette advertising in magazines a full seven years ago, where are Time, Inc. and the American Legacy Foundation - former corporate partners - in 2012? Time, Inc. continues to expose youth to cigarette advertising in magazines, and Legacy remains silent on the issue. You would think that after the honors it bestowed upon Time, Legacy would be livid that the corporation has not, by seven years after the award, finally extended its policy of not taking cigarette advertising in some of its magazines to all of its magazines.

Monday, April 16, 2012

Recently, the Public Health Advocacy Institute (PHAI) petitioned the Food and Drug Administration (FDA) to "investigate and take enforcement action against" the Coca-Cola Company for including the National Heart Lung and Blood Institute’s (NHLBI) “The Heart Truth” Red Dress logo on its diet Coke cans.

According to PHAI's statement: "The Public Health Advocacy Institute is asking the FDA to investigate and take enforcement action against The Coca-Cola Company’s unlawful use of heart health claims on cans of Diet Coke. In February of 2010, 2011 and 2012, The Coca-Cola Company has released Diet Coke cans labeled with a large red heart symbol, the National Heart Lung and Blood Institute’s “The Heart Truth” Red Dress logo, and references to women’s heart health. Taken together, the large red heart symbol, the Red Dress logo and references to heart health imply a relationship between consuming a specific food, Diet Coke, and reduced risk for heart disease. ... The use of the heart symbol, the phrase “The Heart Truth” and the reference to a national health organization implies that Diet Coke consumption is beneficial to heart health. This claim is not supported by scientific evidence and is not otherwise allowed under FDA regulations."

"This type of misbranding is especially damaging to the public because it unequivocally links the product to a desired health outcome through multiple uses of the word “heart” and the use of a heart symbol—expressly the type of symbols, third party references and words the FDA references in its regulations and guidance on health claims for the food industry. The FDA should act immediately to investigate The Coca-Cola Company’s unlawful use of this health claim, issue the appropriate warning letter and take enforcement action as necessary."

As I have pointed out previously, the NHLBI has accepted the Coca-Cola Company as a corporate sponsor for its Heart Truth campaign. By allowing Coca-Cola to be a partner, the NHLBI has allowed Coca-Cola to boast on its web site that: "Our research with consumers has told us that women today are increasingly mindful of making choices that positively impact their lives. For them, drinking Diet Coke is an essential part of their modern pursuit of well-being."

Thus, in addition to making an implied claim that diet soda is helpful in preventing heart disease, the partnership with NHLBI is also helping the Coca-Cola Company to achieve an improved corporate image, positive brand associations with health, and free marketing for diet Coke.

The Rest of the Story

As pointed out in a MinnPostarticle, there is no evidence that diet soda promotes heart health and in fact, there is significant evidence that diet soda consumption is linked to adverse health effects. At least two studies have demonstrated that diet soda consumption is associated with the metabolic syndrome, a constellation of adverse medical conditions that contribute towards heart disease. There is also evidence that "the artificial sweetener in the diet soda promotes weight gain and metabolic syndrome."

According to the article: "An animal study just published in the journal Behavioral Neuroscience seems to support that theory. It found a link between a no-calorie sweetener (saccharin) and weight gain."

The rest of the story is that thanks to its corporate partnership with the Coca-Cola Company, the NHLBI is helping to spread the message that diet soda helps prevent heart disease, helping Coca-Cola to market diet Coke, helping to improve the corporate image of the Coca-Cola Company, and promoting the use of Coca-Cola products. In other words, through this partnership, the NHLBI is promoting heart disease, albeit unintentionally.

Frankly, I don't think that Coca-Cola really needs this help in marketing its products from the NHLBI and American Cancer Society. The company seems to be doing pretty well on its own, selling 1.4 billion servings of its beverages each day.

What we need is a federal agency that will actually help fight obesity, heart disease, and cancer, rather than help promote and market products that contribute to these problems.

A new study published online ahead of print in the journal Addiction reports that nicotine replacement therapy (NRT) is effective for smoking cessation among smokers who have lapsed early in treatment. The study examined 6-week and 10-week cessation rates among smokers who lapsed during weeks 3-5 in clinical trials of nicotine patches. Compared to those using placebo, the NRT users were significantly more likely to be smoke-free at weeks 6 and 10.

According to the study: "Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. ... Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3–5 of treatment in a randomized, double-blind placebo-controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. ... Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR) = 11.0, P < 0.001] and at 10 weeks (9.6% versus 2.6%; RR = 3.7, P < 0.001)."

The study concludes: "Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking."

The Rest of the Story

I certainly don't contest the recommendation that NRT users who lapse early in treatment should not give up. They should continue using the patch to see if they can achieve smoking cessation. However, I do have a problem with the degree to which the paper considers NRT to be an effective strategy for smoking cessation.

Among those who lapsed early in treatment, the relative risk of abstinence at 10 weeks in the nicotine patch group compared to the placebo groups is 3.7. However, the absolute prevalence of abstinence at 10 weeks among the nicotine patch group is only 9.6%. This means that the overwhelming majority of smokers who lapse early in treatment are going to be unsuccessful, ultimately, in achieving smoking cessation. And this study is only measuring cessation at 10 weeks. Cessation at 6 months and at 1 year would be expected to be much lower than 9.6%.

Initially, I could not see how a treatment with a 90%+ failure rate could be called "effective." However, after reading the "fine print," a possible explanation appears:

"This study was supported by SmithKline Beecham Consumer Healthcare, now GlaxoSmithKline Consumer Healthcare (GSKCH), which markets nicotine replacementmedications for smoking cessation. GSKCH also supported the preparation of this manuscript. Through their work at Pinney Associates, the authors serve as consultants to GSKCH on an exclusive basis on matters related to smoking control and/or nicotine replacement medications. Dr Shiffman and Mr Gitchell also have a financial interest in a venture to develop new nicotine replacement medications."

This is a severe conflict of interest. The authors have a vested personal and professional financial interest in reporting the effectiveness of nicotine replacement therapy. Thus, it is perhaps not surprising that a treatment with a 90%+ failure rate at just 10 weeks is reported as being an effective strategy for this problem.

I think this is emblematic of a larger problem: the financial conflicts of interest created by tobacco control researchers taking money from Big Pharma for consultation or by getting into the business of developing medications themselves have created a situation where I do not believe the results of research on NRT treatment are being reported objectively or fairly. It is not appropriate, in my view, to tout a medication with a 90%+ failure rate as an "effective" approach to smoking cessation treatment. I think we can, and must do considerably better than that.

I would call NRT a dismal failure, not an effective strategy for smoking cessation. And I think the evidence base bears this out. This study itself supports my conclusion, as it demonstrates that the overwhelming majority of patients who lapse early in NRT treatment - greater than 90% of them - will ultimately fail in achieving smoking cessation, even just 10 weeks out from the start of treatment.

There is nothing wrong with a pharmaceutical company like GlaxoSmithKline funding a study like this, nor is there anything wrong with researchers taking money from GlaxoSmithKline to conduct a clinical trial of the effectiveness of NRT. However, I do think it is a major problem when investigators with personal financial interests in the drugs they are studying conduct and report the results of clinical trials designed to test the effectiveness of those drugs.

Generally, here at the Boston University Medical Center, we do not allow researchers with such financial conflicts of interest to participate as investigators in clinical trials. The Department of Medicine has an outright prohibition of such investigator involvement in clinical trials. These conflict of interest policies are designed to help prevent exactly the situation that has arisen with the NRT research literature. The rest of the story is that the reporting of these studies has the appearance of having lost scientific objectivity and a meaningful, real-world perspective because of these severe financial conflicts of interest.

Friday, April 13, 2012

The Illinois Senate has passed a bill that would allow hospitals that exclusively treat cancer patients to discriminate against smokers and smokeless tobacco users in their hiring by systematically refusing to hire such individuals. Illinois currently has a law that prevents this type of employment discrimination so a law would be needed in order to allow employers to refuse to hire tobacco users.

According to an article in the Daily Herald: "The proposal, from state Sen. Dan Duffy, lets for-profit companies that only treat cancer patients not hire someone because they smoke or use other tobacco products. “That has an impact on people, when they go in (for treatment) and smell that smoke,” the Lake Barrington Republican said. ... “Their sole mission is to cure cancer, not cause cancer,” Duffy said of the Cancer Treatment Centers."

The Rest of the Story

I wasn't aware that seeing a smoker could cause cancer. That's the implication of Senator Duffy's justification for this policy. He argues that the policy is justified because cancer treatment centers should not be "causing" cancer. But in what way does seeing a smoker or smokeless tobacco user "cause" cancer?

Certainly secondhand smoke is a cause of cancer. But the bill does not outlaw secondhand smoke in these cancer treatment centers, it allow for the outlaw of smokers and other tobacco users. The cancer treatment centers already have the authority to ban smoking and other forms of tobacco use in their workplaces. And I bet that most, if not all of them, already do that. But clearly, the presence of a smoker in the workplace does not cause cancer.

Perhaps the argument is that the thirdhand smoke, the smoke exhaled by smokers long after they stop smoking or the smoke that comes off of their clothing, may be a cause of cancer. However, there is absolutely no evidence to support this hypothesis. Moreover, if that were the true motivation for the policy, then why would smokeless tobacco users be included? There is no thirdhand smoke involved.

Another concern of Senator Duffy's is that people going in for treatment will "smell that smoke." But this can be avoided simply by banning smoking in the workplace. That eliminates the smoke.

Perhaps the argument is that patients will smell the residue of smoke particles that have settled on the clothing or skin of smokers. But the workplace has the right to regulate the behavior of employees on the job. The employer can forbid employees from smoking during the work day. And again, that justification wouldn't apply to a ban on smokeless tobacco users.

Clearly, there is something more behind this proposal, beyond merely the desire to protect the health of the patients at these cancer treatment centers. Since smokeless tobacco products are included in the policy, it is apparent that the true motivation is to make a public statement of disapproval of tobacco use. The legislature has every right to make public statements disapproving of tobacco use, but authorizing employment discrimination against tobacco users is not the appropriate way to make that statement.

If the legislature really wants to do something to show its "disapproval" for tobacco use, then why doesn't it allocate a substantial proportion of its Master Settlement Agreement money towards tobacco prevention and treatment, as it was supposed to do in the first place? Discriminating against smokers does not help smokers in any way, nor does it serve to protect the public's health. In contrast, allocating money towards a tobacco prevention and treatment program would both aid smokers and protect the public's health.

In fiscal year 2012, Illinois is spending just $9.5 million on tobacco prevention, making it the 33rd state in the nation in per capita spending for tobacco prevention, with a spending level that is only 6.1% of that recommended by the Centers for Disease Control and Prevention. According to the Campaign for Tobacco-Free Kids: "Illinois’s spending on tobacco prevention amounts to 1.1% of the estimated $856 million in tobacco generated revenue the state collects each year from settlement payments and tobacco taxes."

The rest of the story is that tobacco control efforts have become largely misdirected in recent years. Instead of focusing on the evidence-based interventions that we know will make a difference in reducing smoking and actually improving the public's health, many states are focusing instead on policies designed to discriminate against and punish smokers and other tobacco users, rather than help them. States are diverting billions of dollars in tobacco settlement money away from the original purpose of these funds - which was to prevent tobacco use - and using the money for a wide range of unrelated purposes instead.

If the Illinois legislature really wants to make a statement to the state and the country about the public health burden of smoking, then it ought to put its money where its mouth is and allocate a substantial portion of MSA revenues to tobacco prevention and treatment, rather than devoting its time to allowing employment discrimination against tobacco users.

Thursday, April 12, 2012

"Step on the scale, please." That's what job applicants are being told at a Texas hospital, which has instituted a policy of not hiring anyone with a body mass index (BMI) over 35, according to an article in the Texas Tribune.

According to the article: "There have been undercurrents of weight discrimination in the workplace for years, but a Texas hospital decided to go anti-fat full throttle. A Texas newspaper recently reported about a fat-averse Texas hospital - Citizens Medical Center in Victoria, Texas - and its unheard-of policy of refusing to hire anyone with a body mass index of more than 35."

"The policy, according to The Texas Tribune, states:

... an employee's physique "should fit with a representational image or specific mental projection of the job of a healthcare professional," including an appearance "free from distraction" for hospital patients.

"The majority of our patients are over 65, and they have expectations that cannot be ignored in terms of personal appearance," hospital chief executive David Brown said in an interview. "We have the ability as an employer to characterize our process and to have a policy that says what's best for our business and for our patients."

The Rest of the Story

As was predicted by many of my readers, the trend of not hiring smokers has now spread to not hiring obese people.

The most important point from this story is that the exact reasoning being used by anti-smoking advocates to support not hiring smokers supports exactly what Citizens Medical Center is doing. Once you support employment discrimination to save money, create a certain public image, or send a message, then it becomes justified not only for smokers but for any group that engages in unhealthy, private, and legal personal behaviors.

It appears that a major factor for the hospital's decision was the fact that older patients do not like looking at fat people. Let's face it. That's what the hospital executive director means when he says: "they have expectations that cannot be ignored in terms of personal appearance."

So what this essentially boils down to - the rest of the story - is that Citizens Medical Center is refusing to employ the obese because it is afraid that older patients do not want to have to look at fat people. This is about as despicable as one can get in hiring policies without breaking the law.

At very least, the hospital should change its name to reflect the fact that it no longer treats all "citizens" equally. The hospital ought to rename itself Thin Citizens Medical Center.

Wednesday, April 11, 2012

In a press release issued last week, Public Citizen condemned the World Trade Organization's (WTO) final ruling on Indonesia's international trade complaint, in which the WTO held that the U.S. ban on clove and other flavored cigarettes, with an exemption for menthol, violated a number of trade agreements. Public Citizen urged the U.S. not to comply with the WTO ruling.

The April 4 press release states: "With today’s ruling, the WTO Appellate Body has now ordered the U.S. to water down or get rid of a key plank of its landmark Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA), one of the few policy achievements of the Obama administration’s first term. The act banned sale of candy and other sweet-flavored cigarettes used to attract children to smoking. 'The Obama administration and Congress must not bow to yet another ruling from a so-called trade agreement tribunal demanding that the U.S. get rid of yet another important health or environmental policy,' said Lori Wallach, director of Public Citizen’s Global Trade Watch. 'The Obama administration must stand with the thousands of Americans who have signed a Consumer Rights Pledge calling on the U.S. to not comply with these illegitimate trade pact rulings.'"

According to the press release: "While the FSPTCA actually does contemplate extending the ban to menthol cigarettes, U.S. lawmakers advocated for a gradual approach to menthols, which are smoked (unlike other sweet cigarettes) primarily by adults. Policymakers had concerns that banning cigarettes primarily smoked by adults would have created dangerous black market activities and would not target teenage smoking. The WTO panel and Appellate Body gave little weight to these science-backed arguments and effectively concluded that imports have to be carved out from nations’ regulatory schemes."

The Rest of the Story

Unlike much of the great work from Public Citizen, this particular press release is seriously flawed. First, there are some serious factual errors. The release argues that unlike other "sweet" cigarettes, menthol cigarettes are smoked primarily by adults. There is no evidence upon which to base this claim. Almost no youths smoke "sweet" cigarettes (or smoked them prior to the ban). The primary brands smoked by youth are Marlboro, Camel, and Newport, not chocolate, strawberry, or banana-flavored cigarettes. However, menthol cigarettes are extremely popular among youth, making up about half of the cigarettes smoked by youth smokers.

Thus, it is false to state that unlike "sweet" cigarettes, menthol cigarettes are smoked primarily by adults, and that a ban on menthol cigarettes would therefore not target youth smoking. On the contrary, a menthol ban would specifically target youth because half of youths smoke menthol cigarettes. In addition, the press release ignores a large body of evidence showing that menthol serves to reduce the harsh sensation produced by tobacco smoke, thus making it easier to introduce youth to cigarettes.

There is no doubt, then, that a menthol ban would be a policy specifically designed to reduce youth smoking.

A second major flaw in the press release is that although it attacks the WTO for putting politics and economics ahead of public health protection, Public Citizen does exactly the same thing in arguing that a menthol ban should not be pursued because it would create a "dangerous black market activities." In making this argument, for which there is little evidence, Public Citizen is borrowing a page from the tobacco companies, adopting their argument against a menthol ban. Public Citizen sounds more like it is interested in protecting tobacco company profits than in substantially improving the public's health by reducing youth smoking.

Finally, the press release incorrectly interprets the options that the U.S. has to comply with the WTO ruling. Public Citizen argues that there are only two options: (1) water down the law by exempting clove cigarettes; or (2) get rid of the ban on cigarette flavors entirely.

But this ignores a third option: the U.S. could extend the cigarette flavoring ban to include all flavorings (i.e., menthol). This would not only put it in compliance with the WTO ruling but it would also make the flavoring ban provision a public health measure rather than purely a political measure. It would actually do something. As I have pointed out previously, the current flavoring ban got rid of exactly zero cigarettes made by Big Tobacco, and affected less than 0.01% of the market. In contrast, a menthol ban would affect about a quarter of the market and more importantly, 50% of the youth market.

The rest of the story is that in condemning the WTO for putting politics and economics ahead of public health, the press release does exactly the same thing by arguing against a menthol ban because it might lead to some contraband cigarettes. The truth is that the menthol exemption has no scientific basis, but was inserted solely to appease tobacco companies in order to retain the support of Philip Morris for the FDA tobacco legislation. It was a pure political compromise, not a scientific-based policy.

This in no way affects my deep admiration for Public Citizen and the great work that it does. However, on this particular issue, it appears that either the group didn't have the full background information or didn't completely think the issue through.

Monday, April 09, 2012

A commentary published online ahead of print last Friday in the journal Addiction, co-authored by Dr. Ted Wagener of the University of Oklahoma, Dr. Belinda Borrelli of Brown University, and me, argues that a more balanced consideration of electronic cigarettes is needed, as the previous literature and scientific debate over these products has been dominated by negative perspectives that have not appropriately taken into consideration their potential and established benefits.

This commentary was written partially in response to Perspective article in the New England Journal of Medicine by Cobb & Abrams, who argued that electronic cigarettes are ineffective for smoking cessation because they do not deliver nicotine adequately for that purpose.

In the commentary, we write: "Cobb & Abrams argue that e-cigarettes are unlikely to be useful for smoking cessation because of ineffective nicotine delivery, as evidenced by low plasma levels of nicotine by the smokers who used them. However, the study [7] that they cite to support this argument actually showed that one e-cigarette brand was able to significantly reduce subjective craving for cigarettes despite low plasma levels of nicotine. Another study [8], not mentioned by Cobb & Abrams, found that e-cigarettes not only deliver nicotine effectively (more rapidly than a nicotine inhaler), but that they significantly reduce cigarette craving and number of cigarettes smoked at a level similar to that of nicotine replacement products. Furthermore, a recent clinical trial [9] published after the Cobb & Abrams article showed that e-cigarette use may motivate quitting. Among 40 smokers who were initially not interested in quitting but who were asked to use the e-cigarette ad libitum, 22.5% achieved sustained smoking abstinence (biochemically verified) at 6-month follow-up [9]. Furthermore, an additional 12.5% and 32.5% reduced their smoking by [at least] 80% and [at least] 50%, respectively [9]."

We note that: "Several survey studies support these findings. In a large international survey of current, former or never users of e-cigarettes, 72% of users reported that e-cigarettes helped them to deal with cravings and withdrawal symptoms, 92% reported reductions in their smoking when using e-cigarettes, and only 10% reported that they experienced the urge to smoke tobacco cigarettes when using the e-cigarette [10]. Moreover, of more than 2000 former smokers in this survey, 96% reported that the e-cigarette helped them to stop smoking, and 79% reported fearing that they would start smoking again if they stopped using it [10]."

Our most important conclusion is: "Consequently, removing e-cigarettes from the market or discouraging their use could harm public health by depriving smokers of a potentially important option for smoking cessation."

We also note that electronic cigarettes offer another benefit that has largely been overlooked: they could potentially reduce secondhand smoke exposure substantially for nonsmokers, especially for children who live in homes with smokers who may now experience high levels of exposure.

Finally, the commentary discusses how the FDA misled the public into believing that electronic cigarettes had been shown to pose a large cancer risk by distorting the findings of its laboratory study of these products:

"We also encourage e-cigarette investigators to draw conclusions within the appropriate context to prevent misleading conclusions. For example, the FDA held a press conference during which it warned consumers not to use e-cigarettes because of the presence of toxic chemicals, including diethylene glycol and carcinogens (tobacco-specific nitrosamines) [18]. What the FDA did not report was that it detected only trace levels of carcinogens (0.07–0.2% of the corresponding levels in cigarettes) [19,20] at levels similar to the nicotine patch and nicotine gum, and found diethylene glycol in only one of the 18 samples tested (a chemical that has not been found in any other brand since) [20]. Viewed in this context, instead of warning consumers not to use e-cigarettes we would argue that these data suggest that e-cigarettes may pose much lower carcinogenicity than regular cigarettes and are probably similar in carcinogenicity to FDA-approved nicotine replacement products."

The Rest of the Story

I believe that FDA regulation of electronic cigarettes is necessary in order to address basic quality control issues and to monitor product use to ensure that youth do not begin to experiment with these devices. However, rather than throw electronic cigarettes out with the anti-harm reduction mindset that has gripped much of the anti-smoking movement, I believe that federal policy should embrace these products as a potentially promising strategy that could save countless lives by helping smokers quit at rates not seen with the dismally effective current "FDA-approved" strategies.

Thursday, April 05, 2012

An appeals panel of the World Trade Organization (WTO) yesterday upheld an earlier decision of the WTO which found that the United States' ban on flavored cigarettes, with an exemption for menthol cigarettes, is discriminatory and therefore violates a number of international trade agreements.

This ruling confirms my earlier analysis, in which I concluded that: "the Family Smoking Prevention and Tobacco Control Act's ban on flavored cigarettes - including clove cigarettes - but with an exemption for menthol cigarettes does violate international trade agreements. Specifically, it violates Articles 2.1 and 2.2 of the Technical Barriers to Trade Agreement, Article 3.4 of the General Agreement on Tariffs and Trade, and Articles 5.4 and 5.5 of the Agreement on the Application of Sanitary and Phytosanitary Measures. Moreover, not only is the U.S. appeal of the WTO's decision flawed in its defense of the discriminatory treatment of menthol cigarettes vs. clove cigarettes, but the appeals brief essentially admits that the reason for the differential treatment of these products was political, not based on public health concerns."

The Rest of the Story

The rest of the story is that the hypocrisy of the national anti-smoking groups and politicians who crafted the Tobacco Act has now been thoroughly exposed. The Tobacco Act was largely a political show-piece, designed to make it look like anti-smoking groups and politicians are taking on Big Tobacco, when in fact they are protecting the domestic cigarette market.

There was no public health rationale for exempting menthol cigarettes, which are smoked by half of youth smokers and by 75% of African-American smokers, but banning chocolate, strawberry, cherry, clove, pineapple, and banana cigarettes, which were smoked by less than 0.01% of smokers.

The U.S. now has three options:

1. It can comply with the WTO ruling by repealing the ban on flavored cigarettes.

2. It can comply with the WTO ruling by extending the flavored cigarette ban to include menthol cigarettes, thus eliminating the discriminatory treatment of clove cigarettes.

3. It can ignore the WTO ruling, continue to enforce the ban on flavored cigarettes other than menthol, and risk retaliation by Indonesia.

My guess is that the U.S. will choose the third option. We have never seemed to have much trouble thumbing our noses at the rest of the world, and I don't see any reason why we would stop now.

In the study, the authors used state-specific data from the Behavioral Risk Factor Surveillance System (BRFSS) surveys to determine the prevalence of self-reported heart attacks one year prior to the implementation of a statewide smoking ban and in 2009, after the smoking ban had been in effect. There were 17 states included in the study. Each had enacted a statewide smoking ban in either 2006, 2007, or 2008. For a smoking ban enacted in 2006, data from the 2005 BRFSS would be compared to data from the 2009 BRFSS. For a smoking ban enacted in 2008, data from the 2007 BRFSS would be compared to data from the 2009 BRFSS.

In this way, the study was able to compare changes in the prevalence of self-reported heart attacks among adults from before to after the state smoking bans in these 17 states.

The results were reported as follows: "Ten of the 17 states/territories (58.8%) were found to have a significant decrease in the prevalence of CHD/angina (Arizona, District of Columbia, Hawaii, New Hampshire, New Jersey, New Mexico, Pennsylvania) or AMI (District of Columbia, Hawaii, Iowa, Minnesota, New Hampshire, New Jersey, Puerto Rico) between baseline and 2009. Two states/territories (11.8%) had a significant increase in the prevalence of CHD/angina (Colorado and Louisiana) between baseline and 2009. Four states (23.5%) had an increase in the prevalence of AMI (Colorado, Louisiana, Nevada, Pennsylvania) between baseline and 2009, but these increases were not significant."

Based on these results, the paper concludes: "The data suggest that CIAAs reduce the prevalence of current smokers and adverse cardiovascular outcomes between 1 and 4 years following implementation (average time between baseline and 2009 was 3.06 years). State/territory-wide reductions in the prevalence of CHD/angina or AMI were observed 1 year (Iowa and Pennsylvania), 2 years (Arizona, District of Columbia, Minnesota, New Hampshire, New Mexico, Puerto Rico) and 3 years (Hawaii, New Jersey, Ohio) after CIAA implementation. Overall, 10 of the 17 states/territories (58.8%) had a decrease in the prevalence of CHD/angina or AMI. ... In conclusion, state/territory-wide CIAAs appear to significantly reduce the prevalence of CHD/angina, AMI, and current and former smokers in the immediate period following CIAA implementation (1–4 years)."

The paper's abstract concludes: "State/territory-wide CIAAs are beneficial in reducing adverse cardiovascular health outcomes in the short term. The prevalence of AMI, CHD/angina, and former and current smokers decreased significantly following CIAA implementation."

The Rest of the Story

There are two major flaws of this study which render its conclusion invalid.

1. There is no control group.

First, there is no control group. The study simply compares changes in self-reported prevalence of heart attacks in states with smoking bans from approximately 2006 to 2009. The study finds that in some states, there was a significant decline during this three-year period. However, without knowing what happened in states without a smoking ban, it is impossible to attribute this change in heart attack prevalence to the smoking ban. One needs to know what was the change in heart attack prevalence from 2006 to 2009 in states that did not enact smoking bans.

The study does not report this information. However, from the Health Care Utilization Project (HCUP) data, we can obtain the changes in hospital discharges with a primary diagnosis of heart attack (i.e., incident heart attacks) in states without smoking bans between the years 2006 and 2009. Here are the data for all states without smoking bans in the HCUP database for which there are data for these years (the last column shows the percentage change from 2006 to 2009):

State

2006

2009

SC

9825

8890

-9.5

OK

8687

8030

-7.6

AR

7192

6837

-4.9

KY

12839

12444

-3.1

MO

15198

14310

-5.8

TN

17229

16493

-4.3

WV

6645

5891

-11.3

TOTAL

77615

72895

-6.1

From this table, one can see that in every state without a smoking ban for which HCUP data are available during the study period, there was a substantial decline in heart attacks, ranging from a decline of 3.1% in Kentucky to a decline of 11.3% in West Virginia. Overall, the decline in heart attacks in these 7 states without smoking bans was 6.1% from 2006 to 2009.

Therefore, how can this study conclude that the decline in self-reported heart attacks in the 17 smoking ban states from 2006 to 2009 was different than what would have been observed in the absence of these bans. Clearly, there is a secular trend of declining incident heart attacks in the United States that is independent of statewide smoking bans.

Given this baseline secular trend, the study cannot conclude that the observed declines in self-reported heart attacks observed in the 17 study states were attributable to the smoking bans in those states, as opposed to simply reflecting underlying secular trends, which are readily observable in states without such smoking bans.

2. The study conducts the wrong statistical analysis.

The study's conclusion that the smoking bans led to a significant reduction in heart attacks is based on the observation that in 10 of the 17 states, the prevalence of heart attacks declined. Of course, another way to look at this is to say that in 7 of the 17 states, the prevalence of heart attacks increased. The real question is this: if there were no true change in heart attacks, what percentage of the time would 10 out of 17 states show a decrease in heart attacks by chance alone?

Think of it this way. Suppose you flip a coin 17 times and come up with 10 heads. Can you conclude that this is not a fair coin, and that it must be weighted more heavily towards heads?

Well one can calculate the probability of obtaining 10 or more heads out of 17 coin tosses with a fair coin. Using the binomial distribution, one can determine that if one flips a fair coin 17 times, the chances of getting at least 10 heads is 31.5%.

Thus, by chance alone, if one were to examine changes in heart attack prevalence in 17 states, one would find that heart attacks decreased in 10 of those 17 states 31.5% of the time (if there were actually no true change in heart attacks). This is far beyond any reasonable level of statistical significance (which is usually set at about 5%).

Thus, the reasoning used by the study to conclude that there was a significant effect of the smoking bans on heart attacks is flawed. The truth is that the observed results (10 out of 17 states showing a decline in heart attacks) would occur by chance about 31% of the time, in the absence of any effect of smoking bans on heart attacks.

A more powerful statistical analysis in this situation would be to calculate the change in heart attack prevalence for each of the 17 states and then determine whether the average change in heart attacks across the states differs significantly from zero, based on standard errors that take into account the total number of observations (i.e., states).

If one conducts this analysis, one will find that the average change in heart attack prevalence among the 17 states is -0.34 percentage points. However, the standard deviation is 0.42 percentage points. Using these data, we can construct a 95% confidence interval for the change in heart attack prevalence, which is [-0.13 to -0.56]. Thus, it turns out that the change in heart attack prevalence is statistically significant.

From this study, then, one can conclude that there was a small, but significant decline in heart attacks in the 17 intervention states. However, in the absence of data from the control states, one cannot conclude that this small decline in heart attack prevalence was attributable to the smoking bans in these states.

Tuesday, April 03, 2012

Last week, the FDA released a draft guidance for tobacco companies on how to report the levels of 20 harmful constituents in tobacco smoke. The FDA has identified a total of 93 hazardous or potentially hazardous constituents, but will not require tobacco companies to report on the levels of all 93 chemicals at this time. Instead, FDA will allow the companies to focus on 20 selected harmful constituents.

The constituents that need to be reported for each brand of tobacco product are as follows (the first column is for cigarettes, the second column is for smokeless tobacco, and the third column is for roll your own tobacco):

Acetaldehyde

Acetaldehyde

Ammonia

Acrolein

Arsenic

Arsenic

Acrylonitrile

Benzo[a]pyrene

Cadmium

4-Aminobiphenyl

Cadmium

Nicotine (total)

1-Aminonaphthalene

Crotonaldehyde

NNK*

2-Aminonaphthalene

Formaldehyde

NNN**

Ammonia

Nicotine (total and free)

Benzene

NNK*

Benzo[a]pyrene

NNN**

1,3-Butadiene

Carbon monoxide

Crotonaldehyde

Formaldehyde

Isoprene

Nicotine (total)

NNK*

NNN**

Toluene

The Rest of the Story

This entire exercise is a huge waste of time. There is nothing that will be learned from the exercise that will either:

(1) provide meaningful or helpful information to consumers; or

(2) provide critical information to the Agency to allow it to develop a strategy to produce substantially safer cigarettes.

If anything, this information is potentially deceptive, as:

1. These constituents represent only a small fraction of the chemicals present in tobacco smoke.

2. No one actually knows which constituents, and in what combinations or at what levels, are responsible for each of the many diseases caused by tobacco smoke.

3. Lowering levels of certain of these constituents may have no effect on overall health risks.

4. Products with lower levels of certain of these constituents may or may not be safer than other cigarettes.

It must be remembered that there are between 10,000 and 100,000 chemicals in tobacco smoke, most of which have not yet been identified. Most likely, the majority of hazardous chemical constituents of tobacco smoke have not yet been identified. It is naive to think that by controlling levels of certain of these 20 selected chemicals, one can control the level of risk posed by different brands of cigarettes.

The entire strategy makes no scientific sense, is not founded in any scientific evidence base, is misleading and deceptive at the core, and represents a tremendous waste of time and resources. This is regulation for regulation's sake, and there is no public health benefit of these regulations. If anything, it is a huge distraction from the types of public health efforts that are actually needed to effectively address the problem of tobacco-related morbidity and mortality.

So in my view, the Secretary of Health and Human Services is deceiving the American public when she states that: "Today’s actions [the issuing of guidances on modified risk tobacco products and harmful constituents] represent critical steps forward on providing Americans with the facts about the dangers of tobacco use and to stop children from smoking."

Neither of these actions will do anything to help provide Americans with the facts about the dangers of tobacco use, nor will they do anything to stop children from smoking.

That the Department of Health and Human Services and the FDA see these actions as representing "significant" actions to "address the tobacco epidemic" is gravely worrisome.

Monday, April 02, 2012

The Food and Drug Administration (FDA) has released its draft guidance for industry on applications for modified risk tobacco products. Closely following the statute (section 911 of the Family Smoking Prevention and Tobacco Control Act), the guidance document sets forward the most stringent possible interpretation of the statute, putting every possible barrier in front of the successful development and marketing of reduced risk tobacco products, and making it extremely difficult for such products to enter the market.

The Rest of the Story

1. The guidance makes it almost impossible for new reduced risk products to be successfully developed and marketed.

First, the guidance makes it clear that any new tobacco products designed with the purpose of reducing health risk will be treated as new products. As such, they must not only comply with the requirements of section 911, but they also must successfully apply for a new tobacco product designation under section 910. This is an extremely difficult barrier, as the company must be able to show that the tobacco product is appropriate for the protection of the public's health. This will be virtually impossible, because long-term human studies will almost certainly be required to make such a demonstration, but those studies cannot be carried out unless the product is approved for use. In other words, it is essentially a catch-22 situation.

The implication of this aspect of the guidance is that unless a potential modified risk product was already on the market as of February 15, 2007, it will be nearly impossible to achieve FDA approval.

Thus, the first thing that the guidance does is to essentially preclude the development of new or novel reduced risk products. What the guidance does is basically restrict the playing field to products that were already in existence as of February 15, 2007 (e.g., smokeless tobacco products, dissolvable tobacco, electronic cigarettes, etc.). We are likely to see some applications for these presumably lower-risk existing tobacco products seeking designation as modified risk or reduced exposure products. However, there is a virtually insurmountable barrier in front of the successful development of a new reduced risk tobacco product.

Second, the guidance adopts the strictest possible scientific criteria that must be met for existing products to achieve designation as modified risk products. Most notably, the company must successfully address:

"The effect the tobacco product and its marketing may have on tobacco use initiation among non-users"; and

"The effect the tobacco product and its marketing may have on tobacco use behavior among current tobacco users."

Even more specifically, a modified risk product application must:

"contain scientific evidence regarding the effect the product and its marketing will have on increasing the likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application"; and

"provide evidence regarding whether the product and its marketing will increase or decrease the likelihood that existing users of tobacco products who would otherwise stop using such products would instead switch to the tobacco product that is the subject of the application."

To make such demonstrations, a company would have to conduct a clinical trial or long-term observational, quasi-experiment in which the potentially reduced risk product was introduced into the market and marketed as a reduced risk product. Then, the company would have to examine the effects on smoking initiation and on reduced quitting, as outlined above.

The key point is that in order to conduct such studies, the company would have to market the product as a reduced risk product. In the absence of such marketing, we will never know the extent to which the product and its marketing will increase the likelihood that nonsmokers might initiate use of the product or that smokers might switch to the product instead of quitting smoking altogether.

But there is a catch-22 here as well. In order to conduct these studies, the company would have to market the product as a reduced risk product. However, the company is prohibited from doing that until and unless it gains approval from the FDA to market it as a reduced risk product!

This catch-22 essentially creates an insurmountable barrier for the successful approval of a modified risk product designation.

Take, for example, the case of Camel snus. Suppose that Reynolds American decides that it wants to apply for a modified risk designation for Camel snus. Presumably, it would be quite feasible to show that for the individual user, Camel snus is safer than using cigarettes. However, how can Reynolds obtain data to determine whether or not marketing Camel snus as a safer tobacco product will have an effect on youth smoking initiation? Will widespread advertising campaigns that portray Camel snus as safer than cigarettes lead youth to start using tobacco products, since they now may perceive tobacco products to be safer than before?

There is only one way to find out for sure. And that is to market Camel snus as a reduced risk product and measure any changes in youth tobacco use. No laboratory studies, youth surveys, or consumer perception studies are going to adequately be able to predict youths' actual behavior in the face of a massive marketing campaign for Camel snus as a safer tobacco product.

Of course, if Reynolds started marketing Camel snus as a safer tobacco product, it would be in violation of federal law. Hench, the catch-22. And hence, the virtually insurmountable obstacle to the successful designation of a modified risk product.

The following paragraph from the guidance makes it clear just how rigorous the scientific demonstration must be. It also makes it obvious just how impossible it is going to be to conduct studies that allow such a demonstration, especially since the product cannot be marketed in the proposed way until it has been approved:

"The estimates should integrate all of the information regarding the marketing of the product and its potential effects on health, tobacco use behavior and tobacco use initiation to provide an overall assessment of the potential effect that the product’s introduction to the market may have on overall tobacco-related morbidity and mortality. FDA recommends that the applicant estimate the attributable risk of all of the various health effects for various types of individuals in the U.S. population, as well as the total number of individuals of each type. As an illustration, consider a product that an applicant maintains poses one-tenth of the risk of death from lung cancer as compared to smoking cigarettes. FDA recommends that the applicant quantify the potential changes in mortality to the various types of affected individuals in the U.S. population (see bullets below). This would include, among other things, an estimate of the number of smokers who are likely to switch to the product and the subsequent reduction in the number of lives lost due to tobacco use, the number of smokers who may use the product in conjunction with other tobacco products or instead of quitting and the subsequent effect on the number of lives lost due to tobacco use, as well as the number of non-smokers who may initiate use of tobacco with the product and the subsequent increase in the number of lives lost to tobacco use. FDA recommends that a similar approach be used to assess the potential impact on mortality resulting from other diseases, as well as morbidity in the various types of affected individuals in the U.S. population."

The above is a massive research undertaking that could not possibly be done successfully by a single company. It would require a massive research effort from all of the nation's universities over many years, and still could not be accomplished in the absence of actual experiments in which specific products were actually marketed as reduced risk products. Frankly, it's not even clear to me why there is a process for modified risk product applications if the scientific standards are so rigorous that they are virtually impossible to attain.

Third, while the guidance does not make it impossible for companies to achieve modified exposure status for a potentially reduced risk product, it makes it extremely unattractive to do so.

Why? Because a key provision of the guidance is the following: "Applicants seeking exposure modification orders must also demonstrate that testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful, or presents or has been demonstrated to present less of a risk of disease than one or more other commercially marketed tobacco products."

In other words, you can market a product as being a reduced exposure product, but whatever marketing language you use cannot give consumers the impression that the product is in any way safer than any other tobacco product! But if that's the case, then what reason is there for anyone to switch to your product? Why would anyone shift from the most popular products on the market to your product in the absence of thinking that your product might be safer? And what company would want to go to the expense of putting together a modified exposure application only to have to continue marketing their product the way it is currently marketed?

It's like telling Reynolds, in the above example: "You have shown successfully that Camel snus is almost certainly safer than smoking cigarettes because snus contains no lung toxins and is not inhaled. You have our approval, therefore, to adopt a modified exposure designation for Camel snus. Congratulations! ...

... Oh, by the way. When you market Camel snus, you can't tell people that it is safer than smoking cigarettes. And you can't tell people that it contains no lung toxins because that will lead them to believe that it's safer than cigarettes. You can't tell people that it has fewer identified toxins that cigarettes because they might think it's safer."

"So what can we tell people?" Reynolds might then ask.

"That it is an alternative to smoking. Not a safer alternative. Not an alternative that provides reduced levels of carcinogens or reduced levels of toxins. Just an alternative."

To which Reynolds might rightly respond: "Well, gee thanks. That's what we're already telling people. What was the whole point behind our reduced exposure application? That was 50 grand down the drain."

Conclusion

The rest of the story, then, is that the FDA guidance on modified risk tobacco products: (1) makes it almost impossible for new reduced risk products to be successfully developed and marketed; (2) makes it extremely difficult for existing potentially-reduced risk products to successfully achieve a modified risk status; and (3) makes it extremely unattractive for existing potentially-reduced risk products to successfully achieve modified exposure status.

Now this is not necessarily the FDA's fault. The FDA is merely interpreting the statute it was given to work with. We have the anti-smoking groups (such as the Campaign for Tobacco-Free Kids and its friends) and the big-name politicians (such as Representative Waxman and Senators Kennedy and Durbin) to thank for the statute which created this inane situation in the first place.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.